PHYSICA KNEE 6595.54.026

GUDID 08033390194556

PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.26 mm H. 7 mm - Cemented

LIMACORPORATE SPA

Polyethylene patella prosthesis

• Primary Device ID: 08033390194556
• NIH Device Record Key: 4542bc51-b32e-41d1-a3bb-a1435a71e644
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA KNEE
• Version Model Number: 6595.54.026
• Catalog Number: 6595.54.026
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390194556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201084

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-01
• Device Publish Date: 2020-12-24

On-Brand Devices [PHYSICA KNEE]

• 08033390194600: PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.41 mm H. 10 mm - Cem
• 08033390194594: PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.38 mm H. 10 mm - Cem
• 08033390194587: PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.35 mm H. 8,5 mm - Ce
• 08033390194570: PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.32 mm H. 8,5 mm - Ce
• 08033390194563: PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.29 mm H. 7 mm - Ceme
• 08033390194556: PHYSICA Knee (cross-linked UHMWPE with Vitamin E) - Patellar Prostheses Dia.26 mm H. 7 mm - Ceme